Back to resultsPost-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Primary Purpose
Male Infertility
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Standard Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility
Eligibility Criteria
Inclusion Criteria:
- Men scheduled for surgical sperm retrieval for infertility
- Men 18 years and older who can provide informed consent
- No documented allergy to bupivacaine or celecoxib
Exclusion Criteria:
- Prior history of substance abuse
- Any narcotic use within the last 3 months
- Concomitant use of aspirin
- Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
- Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Sites / Locations
- Weill Cornell Medicine Department of Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine
Standard Bupivacaine
Arm Description
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Outcomes
Primary Outcome Measures
Pain Scores 48 Hours After Surgery
Every 8 hours in the first 48 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain.
Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 480 (maximum pain (score of 10) reported each time across 48 hours).
Secondary Outcome Measures
Pain Scores 60 Hours After Surgery
Every 12 hours in the first 60 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain.
Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 600 (maximum pain (score of 10) reported each time across 60 hours).
Pain Scores 7 Days After Surgery
Every 12 hours in the first 7 days post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain.
Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 1680 (maximum pain (score of 10) reported each time across 168 hours).
Narcotic Requirement
Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
Time to Narcotic Rescue
Time (in hours) to first rescue narcotic utilization between the two arms.
Pain Control Satisfaction
Overall satisfaction of pain control regimen self reported on post-operative day 7. The prompt required a yes/no answer. The percent of participants answering "yes" will be compared between the two arms.
Percentage of Patients Not Requiring Any Narcotics
The percentage of patients remaining opiate free by post-operative day 7.
Full Information
NCT ID
NCT03802864
First Posted
January 4, 2019
Last Updated
November 23, 2020
Sponsor
Weill Medical College of Cornell University
Collaborators
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03802864
Brief Title
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Official Title
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Pacira Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The study model is a randomized double blind control trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Arm Title
Standard Bupivacaine
Arm Type
Active Comparator
Arm Description
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
Intervention Type
Drug
Intervention Name(s)
Standard Bupivacaine
Intervention Description
After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
Primary Outcome Measure Information:
Title
Pain Scores 48 Hours After Surgery
Description
Every 8 hours in the first 48 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain.
Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 480 (maximum pain (score of 10) reported each time across 48 hours).
Time Frame
First 48 hours after surgery
Secondary Outcome Measure Information:
Title
Pain Scores 60 Hours After Surgery
Description
Every 12 hours in the first 60 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain.
Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 600 (maximum pain (score of 10) reported each time across 60 hours).
Time Frame
First 60 hours after surgery
Title
Pain Scores 7 Days After Surgery
Description
Every 12 hours in the first 7 days post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain.
Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 1680 (maximum pain (score of 10) reported each time across 168 hours).
Time Frame
First 7 days after surgery
Title
Narcotic Requirement
Description
Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
Time Frame
First 7 days after surgery
Title
Time to Narcotic Rescue
Description
Time (in hours) to first rescue narcotic utilization between the two arms.
Time Frame
First 7 days after surgery
Title
Pain Control Satisfaction
Description
Overall satisfaction of pain control regimen self reported on post-operative day 7. The prompt required a yes/no answer. The percent of participants answering "yes" will be compared between the two arms.
Time Frame
7th day after surgery
Title
Percentage of Patients Not Requiring Any Narcotics
Description
The percentage of patients remaining opiate free by post-operative day 7.
Time Frame
7th day after surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men scheduled for surgical sperm retrieval for infertility
Men 18 years and older who can provide informed consent
No documented allergy to bupivacaine or celecoxib
Exclusion Criteria:
Prior history of substance abuse
Any narcotic use within the last 3 months
Concomitant use of aspirin
Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Hayden, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine Department of Urology
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
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